OcuVerity

Why it matters

Where retina trials lose the endpoint.

Retina trials rest on endpoints such as mean change in best-corrected visual acuity (BCVA), often tested against a narrow non-inferiority margin. A few misclassified enrollments, unwarranted rescue injections or missed safety signals can move that result more than the drug does.

Eligibility is self-adjudicated

Sites apply inclusion and exclusion criteria to their own reading of screening OCT, fundus autofluorescence and fluorescein angiography. Central confirmation, where it exists, often arrives after randomization. Baseline atrophy, glaucomatous damage and epiretinal membrane are recorded but not quantified, so randomization cannot balance them, and vision loss they cause still counts against the primary endpoint.

Rescue decisions are investigator-dependent

Supplemental treatment criteria depend on site-level OCT segmentation and on undefined terms such as "vision-threatening." Investigators are not in equipoise, and reading-center adjudication is reliable but too slow for the visit. Each unwarranted rescue injection dilutes the measured treatment effect and adds a protocol deviation.

Safety oversight is episodic

Events such as intraocular inflammation, vasculitis or IOP elevation are often reviewed on a calendar rather than as they occur. DSMC membership is frequently assembled for availability, not for expertise in the molecule and route of delivery. More potent agents and new delivery platforms raise the stakes.

Protocols assign independent review to interim analyses and often to adverse events. Almost none assign anyone to adjudicate the enrollment itself.

Our four pillars

Independent adjudication at each decision point in the trial.

Each pillar answers one question at a defined point in the study, under a charter agreed with the sponsor. Sponsors can engage all four pillars or any subset.

Enrollment Oversight is the only pillar that acts before randomization. It can prevent an imbalance rather than explain it after unblinding.

PILLAR 1

Enrollment Oversight

Is the right patient in the trial?

Independent adjudication of screening SD-OCT, fundus autofluorescence, fluorescein angiography and OCT angiography against protocol inclusion and exclusion criteria.
Quantitative grading of baseline confounders: geographic atrophy area, RNFL thinning and glaucomatous cupping, epiretinal membrane, vitreomacular traction and prior intraocular surgery.
Arm-level covariate balance reported during enrollment, using prespecified covariates the statistical analysis plan can use.
Duplicate and concurrent-enrollment screening across protocols, with verification of washout and prior anti-VEGF exposure.

DeliverableEligible, query or screen-fail determination returned within the screening window and documented for audit.

PILLAR 2

Rescue Review

Is this supplemental treatment protocol-aligned?

Independent review of every rescue request against prespecified disease-activity criteria: ETDRS letter loss, increase in central subfield thickness, new or persistent intraretinal or subretinal fluid, and new macular hemorrhage.
Over-read of site OCT segmentation to correct measurement error before it drives treatment.
Operational definitions for ambiguous criteria such as "vision-threatening," and consistent handling of repeat rescue.

DeliverableDetermination within hours, inside the treatment window, alongside the investigator's assessment. Fewer deviations and less contamination of the primary endpoint.

PILLAR 3

Safety Review

Is this event related to the drug?

A standing group of retina specialists for real-time adverse event evaluation.
Causality assessment for intraocular inflammation, retinal vasculitis and vascular occlusion, endophthalmitis, IOP elevation, and procedure- or device-related events across intravitreal, suprachoroidal, subretinal and sustained-release delivery.
Pattern detection across sites and arms that separates drug effects from injection technique and manufacturing (CMC) signals.

DeliverableCausality assessment, site guidance, protocol clarification and evidence-based escalation to the DSMC.

PILLAR 4

Data Safety Monitoring

Should the trial continue as designed?

Membership matched to the disease, the molecule class and the route of administration, from gene therapy to tyrosine kinase inhibitors and complement inhibitors.
Charter-defined interim analyses, stopping rules and dose-escalation decisions.
Aggregate benefit–risk review across arms and the full safety database, firewalled from the sponsor and from event-level safety review.

DeliverableRecommendation to continue, modify or pause, delivered to the sponsor under the DSMC charter.

Safety Review and DSMC: two mandates, kept separate

Aspect	Safety Review (Pillar 3)	DSMC (Pillar 4)
Core question	Is this event related to the drug or the delivery?	Should the trial continue, change or stop?
Cadence	Continuous; convened when a signal appears	Scheduled interims plus charter-defined triggers
Scope	Individual events, causality, site technique, device and CMC signals	Aggregate benefit–risk across arms and the full safety database
Output	Causality assessment, site guidance, escalation	Continue, modify or pause recommendation

Working with us

One agreement, a named academic panel, predictable cost.

A single master services agreement covering all four pillars, or any subset.
Rescue Review, Safety Review and DSMC charters drafted with the sponsor during protocol finalization, before first patient in.
Named academic reviewers, screened for conflicts on each program, disclosed to the sponsor and available to regulators.
Defined turnaround commitments for each pillar, with monthly performance reporting.
Every determination documented and auditable for the regulatory submission.
Compensated for judgment, never for an outcome. Independence is written into the contract.

What we don't do

Run the trial

We are not a CRO. We don't manage sites, monitor source data or hold the clinical database.

Grade the primary endpoint

We are not a reading center. We adjudicate clinical decisions; primary endpoint grading stays with the reading center.

Author the submission

We are not a regulatory consultant. We generate the documented, independent evidence that supports it.

OcuVerity is the independent clinical judgment layer between the sites, the reading center and the sponsor.

Looking ahead

AI screens. Physicians decide.

We are developing AI tools to help our specialists work faster: measuring eye scans automatically at screening, flagging within minutes when a patient may need extra treatment, and spotting early warning signs across the study. Every final decision stays with an expert physician. The goal is to catch problems before they affect the trial.

Leadership

Led by experienced clinical trial leaders.

OcuVerity was founded by academic retina specialists with decades of experience leading and overseeing clinical trials around the world.

Debbie Espe

President & Chief Executive Officer

Debbie Espe leads OcuVerity's operations, sponsor partnerships and business development.

Announcing soon

Scientific Advisory Board

Our Scientific Advisory Board will bring together leaders in retina care, clinical trial design and patient safety. Members will be announced soon.

Contact

Planning an eye‑disease clinical trial?

The best time to plan independent oversight is while the study design is being finalized. Tell us about your program and we'll be in touch.

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